Abstract 3346: Design of Multi-center, Randomized, Open-label, Blind-endpoint Trial Comparing Effects of Cilostazol versus Other Anti-platelet Drugs for the In-stent Restenosis after Carotid Artery Stenting : The Carotid Artery Stenting with Cilostazol Addition for Restenosis (CAS-CARE) Trial

Abstract

Background and Purpose: Carotid artery stenting (CAS) is increasingly used to treat high-grade carotid stenosis, but the impact of medication on carotid in-stent restenosis (ISR) has not been shown. The present study was conducted to evaluate the inhibitory effect of cilostazol on ISR, compared to that of other antiplatelet drugs, in patients scheduled to undergo CAS. Methods: The Carotid Artery Stenting with Cilostazol Addition for Restenosis (CAS-CARE) trial is a multi-center, prospective, randomized, open-label, blind-endpoint trial, designed to compare the efficacy of cilostazol versus other anti-platelet therapy on ISR after CAS. Main inclusion criteria are patients with diagnosis of carotid artery stenosis, scheduled for carotid artery stenting within 30 days of enrolment, and aged at 45 - 80 years at time of consent. Patients who suffered an ischemic stroke within 48 hours prior to enrolment or those with aortic arch syndrome, vasculitis, or collagen disease will be excluded from the study. Diagnosis of carotid artery stenosis is based on angiography (NASCET stenosis ratio > 50% for symptomatic lesion or > 80% for asymptomatic lesion), or carotid ultrasound (peak systolic velocity > 130cm/sec for symptomatic lesion or > 230cm/sec for asymptomatic lesion). Nine hundred patients will be randomized into 2 groups: the first group will receive cilostazol from at least 3 days before CAS and continue for 2 years. The second group will never receive cilostazol during the same period. Use of other antiplatelet agents and concomitant drugs is unrestricted in each group. The allocation adjusting factors are presence or absence of symptoms, presence or absence of diabetes mellitus, type of stent scheduled to be used (open cell vs. closed cell), and test center. Follow-up carotid ultrasound will be examined at 6, 12 and 24 months after CAS, and carotid restenosis ≥50% is diagnosed using velocity criteria. The primary outcome is occurrence of in-stent restenosis within 2 years after CAS and time to occurrence. Secondary outcomes include 1) occurrence of in-stent restenosis, new out-stent stenosis, or re-treatment, 2) occurrence of cardiovascular event or death from any cause, 3) occurrence of a hemorrhagic event, and 4) a composite endpoint of them. Conclusion: CAS-CARE will determine whether cilostazol can prevent restenosis after carotid artery stenting with an acceptable risk profile.